Endovascular Aneurysm Treatment with the Numen Coil Embolization System : A Prospective Randomized Controlled Open-Label Multicenter Noninferiority Trial in China
Copyright © 2021 Elsevier Inc. All rights reserved..
OBJECTIVE: We investigated the safety and efficacy of the Numen coil compared with the Axium coil in the treatment of intracranial aneurysms.
METHODS: Because CATCH (Coil Application Trial in China) is a prospective randomized controlled open-label noninferiority trial conducted in 10 centers across China, patients who fulfilled the inclusion and exclusion criteria were randomized 1:1 to either a test group (Numen) or a control group (Axium). The primary outcome was based on successful aneurysm occlusion at 6 months follow-up, whereas secondary outcomes included technical success, the recanalization and retreatment rates, and the rate of serious adverse events (SAEs) at 6 months and 12 months follow-up.
RESULTS: Between August 2017 and December 2019, 350 patients presenting with 350 aneurysms were enrolled and randomized. Per-protocol analysis showed that the successful aneurysm occlusion rate at 6 months was 91.18% for the test group compared with 91.85% in the control group, with a difference of -0.68% (P = 0.8419), and the overall mortality during the 30-day follow-up period was 1.19% and 1.81% in the test and control group, respectively, showing no significant difference between the 2 groups (P = 0.6837), whereas the SAE incidence during the 12-month follow-up period was 12.50% and 17.47% in the test and control groups, respectively, which was not statistically significant (P = 0.2222).
CONCLUSIONS: This trial showed that the Numen coil was noninferior to the Axium coil in terms of intracranial aneurysm embolization and can be considered as a safe and effective coil for treating patients with intracranial aneurysm in clinical practice.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:160 |
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| Enthalten in: |
World neurosurgery - 160(2022) vom: 01. Apr., Seite e23-e32 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zhao, Rui [VerfasserIn] |
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| Links: |
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| Themen: |
Aneurysm |
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| Anmerkungen: |
Date Completed 05.04.2022 Date Revised 22.08.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.wneu.2021.11.067 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM334431719 |
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| 245 | 1 | 0 | |a Endovascular Aneurysm Treatment with the Numen Coil Embolization System |b A Prospective Randomized Controlled Open-Label Multicenter Noninferiority Trial in China |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: We investigated the safety and efficacy of the Numen coil compared with the Axium coil in the treatment of intracranial aneurysms | ||
| 520 | |a METHODS: Because CATCH (Coil Application Trial in China) is a prospective randomized controlled open-label noninferiority trial conducted in 10 centers across China, patients who fulfilled the inclusion and exclusion criteria were randomized 1:1 to either a test group (Numen) or a control group (Axium). The primary outcome was based on successful aneurysm occlusion at 6 months follow-up, whereas secondary outcomes included technical success, the recanalization and retreatment rates, and the rate of serious adverse events (SAEs) at 6 months and 12 months follow-up | ||
| 520 | |a RESULTS: Between August 2017 and December 2019, 350 patients presenting with 350 aneurysms were enrolled and randomized. Per-protocol analysis showed that the successful aneurysm occlusion rate at 6 months was 91.18% for the test group compared with 91.85% in the control group, with a difference of -0.68% (P = 0.8419), and the overall mortality during the 30-day follow-up period was 1.19% and 1.81% in the test and control group, respectively, showing no significant difference between the 2 groups (P = 0.6837), whereas the SAE incidence during the 12-month follow-up period was 12.50% and 17.47% in the test and control groups, respectively, which was not statistically significant (P = 0.2222) | ||
| 520 | |a CONCLUSIONS: This trial showed that the Numen coil was noninferior to the Axium coil in terms of intracranial aneurysm embolization and can be considered as a safe and effective coil for treating patients with intracranial aneurysm in clinical practice | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Aneurysm | |
| 650 | 4 | |a Coil | |
| 650 | 4 | |a Complication | |
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